PhRMA Principles on Conduct of Clinical Trials

Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results

Developing new therapies to treat disease and to improve quality of life is a long and complex process. A critical part of that process is clinical research, the study of a pharmaceutical product in humans. Without clinical research studies, no new medicines could be made available to patients.

In sponsoring and conducting clinical research, PhRMA members place great importance on respecting and protecting the safety of research participants. Principles for the conduct of clinical research are set forth in internationally recognized documents, such as the Declaration of Helsinki and the Guideline for Good Clinical Practice of the International Conference on Harmonization. The principles of these and similar reference standards are translated into legal requirements through laws and regulations enforced by national authorities, such as the Food and Drug Administration.

PhRMA members have had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. Many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulatory agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.

In December 2014, a new chapter on Expanded Access to Investigational Drugs was added to the Principles. With this addition, PhRMA member companies commit to establish informational resources to help facilitate awareness of expanded access programs. The revised Principles take effect on June 1, 2015.

These Principles are supplemented by the Principles for Responsible Clinical Trial Data Sharing which were adopted by PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in July 2013. Under those Principles, biopharmaceutical companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to clinical study information, and reaffirm their commitment to publish clinical trial results.